Pravastatin (prav-a-STAT-in)

Lowers high levels of cholesterol and triglycerides (fats) in your blood. Used in combination with a diet program to help keep atherosclerosis (hardening of the arteries) from getting worse. Helps prevent heart attack and stroke in people who have heart disease. This medicine is an HMG-CoA inhibitor, and is sometimes called a "statin."

Brand Name(s):

Pravachol

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food. Take this medicine in the evening or at bedtime, unless your doctor tells you differently.
• Carefully follow your doctor's instructions about diet and exercise. This medicine is only part of a complete plan for lowering cholesterol and triglycerides in your blood.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using cimetidine (Tagamet®), clarithromycin (Biaxin®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), erythromycin (Ery-Tab®), gemfibrozil (Lopid®), itraconazole (Sporanox®), ketoconazole (Nizoral®), niacin, or spironolactone (Aldactone®).
• If you are also taking other medicines to lower your cholesterol (such as cholestyramine, colestipol, Colestid®, or Questran®), take these medicines 4 hours before or at least 1 hour after taking pravastatin.
• Tell your doctor if you usually drink large amounts of alcohol.

Warnings While Using This Medicine:

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you have kidney disease, an underactive thyroid that is not controlled, or a history of liver disease or alcoholism. Tell your doctor if you have an a history of muscle pain or weakness.
• Call your doctor right away if you start to have unexplained muscle pain, tenderness, or weakness especially if with general feeling of discomfort or illness, fever, or dark-colored urine.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine if you have major surgery or a major injury (trauma). You also may need to stop if you develop other serious health problems, such as uncontrolled seizures, a blood infection, or if you have low blood pressure, a problem with the levels of electrolytes in your body, or a metabolic or endocrine disorder.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests will be needed to check for unwanted effects.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain.
• Dark-colored urine or pale stools.
• Decrease in how much or how often you urinate, painful urination.
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches.
• Muscle pain, tenderness, weakness, or cramps.
• Stomach pain, nausea, vomiting, or loss of appetite.
• Unexplained fever.
• Unusual tiredness or weakness.
• Yellowing of the skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, gas, indigestion, or stomach upset.
• Headache or dizziness.
• Rash.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088